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A Phase I-III study to evaluate BBDF-101 for Batten disease

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Trial Profile

A Phase I-III study to evaluate BBDF-101 for Batten disease

Status: Planning
Phase of Trial: Phase II/III

Latest Information Update: 12 May 2023

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At a glance

  • Drugs BBDF 101 (Primary)
  • Indications Neuronal ceroid lipofuscinosis
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 09 May 2023 According to Theranexus media release, patient enrollment is expected to begin in the end of 2023.
  • 09 May 2023 According to Theranexus media release, company announced the receipt of approval from the Food and Drug Administration (FDA) for the design and primary and secondary endpoints of the pivotal phase III study at a meeting with the Division of Rare Disease and Medical Genetics (DRDMG).
  • 11 Aug 2020 According to a Theranexus media release, it plans to launch clinical program in 2021.

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